Beta-glucan and Insulin Sensitivity in Obese Humans

NCT01393210 | Completed

• 1 other identifier: ZPChM-11-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is an important health problem of modern civilization. In Western societies, almost half of the adult population has problems with an increased body weight. Products containing nutritional fiber has been used by humans for thousands of years. However, beta-glucan as biologically active compound, present in these products, has been identified relatively lately. This substance is a polymer of glucose and is present in two forms: 1,3D-1,6D and 1,3D-1,4D. Water-insoluble beta-glucan (1,3D-1,6D) has immunomodulatory properties. The aim of the study was the assessment of the influence of beta-glucan 1,3D-1,6D added to the low-calorie diet on insulin sensitivity and the expression of selected proinflammatory cytokines in adipose tissue and peripheral blood mononuclear cells (PBMC) in obese humans with normal glucose tolerance. The study group consisted of 40 subjects with marked overweight or obesity (body mass index, BMI \> 28 kg/m2), without serious concomitant diseases not taking drugs affecting glucose or lipid metabolism, nonsmokers. Only volunteers, who gave written informed consent, after receiving a full information about the aim and the design of the study, were recruited. At the beginning of the study, after subjects' qualification to the project and before the dietary intervention, the investigators performed:

• anthropometric measurements.
• oral glucose tolerance test.
• euglycemic hyperinsulinemic clamp.
• PBMC isolation before and after the clamp.
• biopsy of subcutaneous adipose tissue before the clamp.
• isolation of mRNA from PBMC and adipose tissue. Then, the expression of the selected genes with the Real Time PCR was measured.
• After the initial visit, participants received detailed instructions about low-calorie diet, with the aim of reduction of 5-7% of body weight and the examples of menu for 14 days. Then, participants were randomly assigned to a group receiving or not beta-glucan preparation, as a addition to the low-calorie diet. Each group consisted of 20 subjects. Subjects assigned to a group receiving beta-glucan, received the preparation (BETA GLUCAN 1,3-1,6 Laboratoria Natury 500mg) together with the detailed instruction of its usage. This preparation is used as a non-prescription diet supplement, and the dose of 500 mg daily is indicated by the manufacturer. After 12 weeks of low-calorie diet, without or with beta-glucan, all the examinations performed at the beginning of the study were repeated.

Conditions

Obesity

Keywords

insulin sensitivity; adipose tissue; inflammation

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  one year

Secondary Outcomes (3)

• body weight

  one year

• amount of visceral adipose tissue

  one year

• expression of selected genes in PBMC and adipose tissue

  one year

Study Arms (2)

low-calorie diet

ACTIVE COMPARATOR

Intervention was low-calorie diet only for 12 weeks.

Other: low-calorie diet

low calorie diet plus beta-glucan

ACTIVE COMPARATOR

Intervention was low-calorie diet plus BETA-GlLUCAN 1.3D-1.6D 500 mg daily for 12 weeks.

Dietary Supplement: low calorie diet plus beta-glucan; Other: low-calorie diet

Interventions

low calorie diet plus beta-glucan DIETARY_SUPPLEMENT

beta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeks

low calorie diet plus beta-glucan

low-calorie diet OTHER

low-calorie diet only for 12 weeks.

low calorie diet plus beta-glucan; low-calorie diet

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• marked overweight or obesity (BMI above 28 kg/m2)
• normal glucose tolerance

You may not qualify if:

• morbid obesity (BMI above 40 kg/m2)
• impaired glucose tolerance or diabetes
• cardiovascular diseases
• other serious disease
• smoking
• usage of drugs known to affect carbohydrate or lipid metabolism

Sponsors & Collaborators

• Marek Straczkowski: lead

Study Sites (1)

Institute of Animal Reproduction and Food Research, Polish Academy of Sciences

Olsztyn, 10-748, Poland

Location

Related Publications (2)

• Danowska M, Stefanowicz M, Straczkowski M. The expression of NFAT family genes in subcutaneous adipose tissue before and after weight loss in obese individuals. Nutr Metab Cardiovasc Dis. 2024 Nov;34(11):2455-2463. doi: 10.1016/j.numecd.2024.06.011. Epub 2024 Jun 20.

  PMID: 39069466 DERIVED

• Nikolajuk A, Stefanowicz M, Straczkowski M, Karczewska-Kupczewska M. Changes in Adipose Tissue Gene Expression of the Core Components of the Hippo Signaling Pathway in Young Adults with Uncomplicated Overweight or Obesity Following Weight Loss. J Nutr. 2023 Mar;153(3):665-672. doi: 10.1016/j.tjnut.2023.01.024. Epub 2023 Jan 26.

  PMID: 36805181 DERIVED

MeSH Terms

Conditions

Obesity; Insulin Resistance; Inflammation

Interventions

Caloric Restriction; beta-Glucans

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Marek Straczkowski, MD, prof.

  Institute of Animal Reproduction and Food Research, Polish Academy of Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: July 13, 2011
• Study Start: May 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 30, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)